Although 160,000 people in the U.S. die each year from lung cancer, accounting for more than a quarter of all cancer deaths, screening for lung cancer remains controversial. Based on results from the National Lung Screening Trial (NLST) in 2011, the U.S. Preventive Services Task Force (USPSTF) issued a B recommendation in favor of low-dose CT screening for high-risk current and former smokers. Due to a provision in the Affordable Care Act, private insurance is now mandated. More recently, the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) concluded that there is only low to intermediate confidence that “there is adequate evidence to determine if the benefits outweigh the harms.” The Centers for Medicare and Medicaid Services (CMS) is expected to issue a final decision on national coverage in 2015.

In a startling break with tradition, the American College of Cardiology and the Society of Thoracic Surgeons will manage and run their own clinical trials testing expanded uses for transcatheter aortic valve replacement (TAVR). The two medical groups have recently been granted an investigational device exemption (IDE) by the FDA for one such trial and hope to gain an IDE for at least two more trials. The news was first reported by The Gray Sheet (subscription required) on February 8.

The new development represents a significant enlargement of the TVT registry, already run by the ACC and STS, which tracks all TAVR usage in the US.

Hospitals across the country received emails from the US Department of Justice on Thursday containing a proposed “Resolution Model” that will allow the hospitals to begin to settle the long-standing and much-feared DOJ investigation into improper Medicare billing for ICDs. The action appears to confirm an article, published earlier in August in Report on Medicare Compliance, that summarized the key details of the novel program.

As reported by ModernHealthcare.com (free registration), the document sent to hospitals contains “instructions to examine questionable implantable defibrillator surgeries on Medicare patients and estimate potential penalties under the False Claims Act.” Some hospitals, according to the story, “have been asked to provide information of hundreds of cases each.”

Hospitals are being asked to perform audits on their cases and to estimate damages, “with the severity of penalties based on whether the hospital had medical reasons to violate CMS rules; if patient harm resulted; if the hospital had prior knowledge or a statistical pattern of non-guideline implants; and if a hospital compliance program was in place.”

In a guest post, electrophysiologist Edward J. Schloss recounts a talk at Heart Rhythm Scientific Sessions 2012 by Suneet Mittal which provided a detailed account of his group’s experience with a Department of Justice investigation of ICD implantation outside of NCD guidelines. More…

From the first early stages of its development, the prospect of transcatheter aortic valve replacement (TAVR) provoked two broad and competing fears:

Regulatory safeguards would kill a promising new technology, denying its life-saving benefits to many thousands of desperately sick people.

The stampede to stake a claim in a promising, highly lucrative new territory would lead to the exploitation and mistreatment of many thousands of desperately sick people.

Remarkably, neither scenario occurred. Instead, at a very early stage, medical societies, regulators, and industry worked together to ensure the smooth introduction of TAVR in the US. The final decision earlier this week by the Centers for Medicare & Medicaid Services (CMS) to provide reimbursement for TAVR was the latest step in a long, ongoing process that, for once, didn’t appear broken, and, in fact, represented an unusual consensus among physicians, regulators, insurers, and other involved parties.

However, in an apparent attempt to inject politics where it’s neither needed nor wanted, Scott Gottlieb, a conservative activist who is a former FDA deputy commissioner and CMS adviser, concludes that the CMS ruling means “that for costly procedures, Washington will be making more of these choices for us.” In a posting on the American Enterprise Institute’s The Enterprise Blog, Gottlieb writes that the decision “is a vivid example of how our healthcare is going to get reimbursed now that Washington calls more of the shots.”

Gottlieb doesn’t make a clear statement that explains his hostility to the CMS decision. Instead, he cites several facts that he thinks makes his case for him. He’s wrong.

For instance, Gottlieb writes:

CMS is also restricting the number of doctors that can perform the new procedure.

Actually, CMS has done nothing of the sort. It has insisted that doctors who perform the procedure have adequate training and that the hospitals where the procedures are performed have sufficient experience and adequate facilities. Perhaps Gottlieb would be happy to send an elderly relative for TAVR to a local community hospital with little experience in the procedure. It was precisely to avoid this scenario that the American College of Cardiology and the Society of Thoracic Surgeons supported CMS in this coverage decision. I fail to see how anyone would benefit by widespread proliferation of TAVR by novice operators at inexperienced centers.Click to continue reading…

The Centers for Medicare & Medicaid Services (CMS) today issued its national coverage decision (NCD) for transcatheter aortic valve replacement (TAVR). As expected, CMS will offer reimbursement for TAVR, but only if a number of criteria are first met. The NCD was initially requested by the American College of Cardiology and the Society of Thoracic Surgeons, responding to concerns that TAVR approval might lead to a stampede of implantations as cardiologists, surgeons, and hospitals sought to stake a claim in a major new territory.

The NCD decision memo outlines a series of conditions that must be met for CMS reimbursement:

The use of an FDA approved device for an FDA approved indication.

Evaluation of the patient by 2 cardiac surgeons.

Performance of the procedure at an institution with sufficient surgical and interventional cardiology experience and expertise, including participation in a prospective national TAVR study and a commitment to the heart team concept. (The memo provides details on two sets of qualifications: one for hospitals without previous TAVR experience and the second for hospitals with TAVR experience.)

Performance by physicians with sufficient experience and expertise.

The patient must be enrolled in, and the physician must participate in a national TAVR registry.

CMS also said it would provide coverage for patients enrolled in clinical studies for new indications, as long as the trials meet a long list of criteria. CMS said that coverage would be denied for indications other than those specifically mentioned in the memo.

On Thursday the Centers for Medicare & Medicaid Services (CMS) released a memo containing details of its proposed Medicare coverage for TAVR (transcatheter aortic valve replacement). The memo is a response to a formal request for national coverage determination (NCD) from the Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC). The memo will be open for public comment until March 3, after which a final determination will be made.